A Study to Assess the Effects of an Oral Dietary Suppleme... | NCT01787461

NCT01787461

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Imedeen	Experimental	Imedeen is the study product	Dietary Supplement: Imedeen
Placebo	Placebo Comparator		Dietary Supplement: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Imedeen	Dietary Supplement	Two tablets per day for 6 months	Imedeen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 24	IGA of overall facial appearance was measured using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.	Baseline, Week 24

Secondary Outcomes

Measure	Description	Time Frame
Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24	IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Baumann Cosmetic and Research Institute		Miami	Florida	33137	United States
TKL Research, Inc.

References Module

Label	URL
To obtain contact information for a study center near you, click here.	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
FG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Imedeen Time Perfection

Safety analysis set included all participants who received at least one dose of the study treatments.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
BG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00095 BG00198 BG002193

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Baseline (n=93,97)

Title	Measurements
	OG0006.04± 1.45 OG0015.81± 1.30

Change at Week 24 (n=92,95)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Change at Week 24: Analysis was performed using an analysis of variance (ANOVA) model with treatment, Glogau classification of photoaging, site, baseline and treatment-by-baseline interaction (if applicable) terms.	ANOVA		0.358		Least Squares (LS) Mean Difference	0.14			2-Sided	95	-0.16	0.44				No	Superiority or Other

Secondary

Photographic Assessment Compared to Baseline of the Participants Overall Facial Appearance by Independent Panel Review Committee (IPRC) at Week 24

IPRC assessment was performed in accordance with the Canfield procedures and rated the improvement relative to Baseline. The investigators used an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.

Posted

Mean

Standard Deviation

units on scale

Week 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Investigator Global Assessment (IGA) of Participant's Overall Facial Appearance at Week 12

m-ITT population included all randomized participants who had at least 1 pre-dose and post-dose assessment value. Here "n" signifies those participants who were evaluable for this measure at specified time- points for each arm, respectively.

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Investigator Assessment of Face at Weeks 12 and 24

Investigator performed the assessment of face (Fine lines/wrinkles (L/W) of the periocular area (A), Fine lines/wrinkles of the perioral area, dark circles (dc) or "bags" under the eye, mottled hyperpigmentation (MH), sallowness/yellowing, roughness/texture) using a numerical severity rating scale of 0 to 9, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts

Secondary

Change From Baseline in Investigator Assessment of Decolletage and Back of Hands at Weeks 12 and 24

Investigator performed the assessment of decolletage and back of hands (crepyness, mottled hyperpigmentation [MH]) using a numerical severity rating scale of 0 to 9 using 1/2 points, where 0 to less than or equal to (<=) 3 signifies Mild; greater than (>) 3 to <=6 signifies Moderate and >6 to <=9 signifies Severe.

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants

Secondary

Participants Improvement Assessment of Face at Week 12 and 24

Participants performed the assessment of face (overall facial (OA) appearance, fine lines and wrinkles (L/W) present in the eye area, upper lip, or cheek areas, under eye dark circles (dc) or bags, discoloration [uneven, patchy, blotchy areas of light and dark, age spots, liver spots], complexion/glow [bright radiant appearance] and smoothness) at Baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the facial parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Secondary

Participant Improvement Assessment of Decolletage, Back of Hands and Body at Week 12 and 24

Participants performed the assessment of decolletage (decolletage overall, decolletage-wrinkling/crinkling (W/C), decolletage-discoloration (DD) and back of hands (back of hands overall, back of hands (BOH) - Fine lines/wrinkles (L/W), back of hands - discoloration) and Body - Dryness (BD) Overall at baseline using a 10-point numerical scale, and at Week 12, 24 using a 7-point improvement scale. At Baseline, participants rated the Decolletage, Back of Hands and Body parameters using a 10-point scale ranging from 1 (Not noticeable) to 10 (Very noticeable). At Week 12 and 24, assessment was performed relative to Baseline using an improvement scale that ranged from -3 to 3 (where -3 = Definite worsening, -2 = Moderate worsening, -1 = Slight worsening, 0 = No change, 1 = Slight improvement, 2 = Moderate improvement, 3 = Definite improvement).

Posted

Mean

Standard Deviation

units on scale

Baseline, Week 12, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Secondary

Change From Baseline in Skin Hydration at Week 6, 12, 18 and 24

DermaLab Combo Skin Lab with an 8-pin probe was used to measure hydration (corneometry). Hydration measurements of the left cheek, left inner arm, and left outer arm were taken (up to 3 measurement).

Posted

Mean

Standard Deviation

microsecond

Baseline, Week 6, 12, 18, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Trans-Epidermal Water Loss (TEWL) at Week 6, 12, 18 and 24

Trans-epidermal water loss (TEWL) measurements were done using DermaLab Combo SkinLab with a cylindrical diffusion chamber (10 mm [millimeter] diameter) containing 2 combined humidity/temperature sensors to determine the amount of water vapor that moves across the stratum corneum. TEWL measurements were taken on the left cheek and the left inner and outer arm (up to 3 measurement).

Posted

Mean

Standard Deviation

gram per square meter per hour

Baseline, Week 6, 12, 18, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts

Secondary

Change From Baseline in Skin Thickness at Week 6, 12,18 and 24

Skin thickness was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

Posted

Mean

Standard Deviation

micrometer

Baseline, Week 6, 12, 18, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants

Secondary

Change From Baseline in Skin Density at Week 6, 12, 18 and 24 (With 100% Calibration Mode)

Skin density was measured using the DUB Cutis (taberna pro medicum), a high frequency and high resolution diagnostic ultrasound system with 100 percent (%) calibration mode. Measurements were taken on the left cheek, and the left inner and outer arm (up to 3 measurement).

Posted

Mean

Standard Deviation

micrometer

Baseline, Week 6, 12, 18, 24

ID	Title	Description
OG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
OG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.			0	95	24	95
EG001	Imedeen	Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.			2	98	29	98

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Thrombosis	Vascular disorders	MedDRA 17.0	Non-systematic Assessment		EG0000 affected95 at risk EG0011 affected98 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.0	Non-systematic Assessment		EG0000 affected95 at risk EG0011 affected98 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected95 at risk EG0012 affected98 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0014 affected98 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected95 at risk EG0011 affected98 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0011 affected98 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0018 affected98 at risk
Tooth infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0012 affected98 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.0	Non-systematic Assessment	EG0004 affected95 at risk EG0013 affected98 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0012 affected98 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0012 affected98 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0012 affected98 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0011 affected98 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0012 affected98 at risk
Headache	Nervous system disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0011 affected98 at risk
Depression	Psychiatric disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0013 affected98 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0012 affected98 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected95 at risk EG0012 affected98 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0001 affected95 at risk EG0012 affected98 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0000 affected95 at risk EG0015 affected98 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected95 at risk EG0010 affected98 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0002 affected95 at risk EG0011 affected98 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.0	Non-systematic Assessment	EG0003 affected95 at risk EG0010 affected98 at risk

ID	Term
C070172	Imedeen